HER2 - human epidermal growth factor receptor 2 - is an important biomarker found in breast and gastric cancers. Results can be read using light microscopy, eliminating the need for a specialized fluorescence microscope. It will be submitted to the U.
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A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a specific therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product. This table lists devices in the order of approval, with most recently approved device at the top. Download a Printable Version of this Table.
Breast Cancer Research and Treatment. In order to investigate the predictive value of in vitro MTT assay for directing chemotherapy of breast cancer patients, from toadvanced breast cancer patients who had evaluable lesions were recruited for a prospective study. The other 10 patients in the MTT resistant group and 73 patients in the control group were given chemotherapy according to clinicians' discretion.
Breast tumors are typically heterogeneous and contain diverse subpopulations of tumor cells with differing phenotypic properties. Planar cultures of cancer cell lines are not viable models of investigation of cell-cell and cell-matrix interactions during tumor development. This article presents an in vitro coculture-based 3-dimensional heterogeneous breast tumor model that can be used in drug resistance and drug delivery investigations.
A chemoresistance assay is a laboratory test used to identify chemotherapeutic agents that may be ineffective against tumor growth. A chemosensitivity assay is a laboratory test performed to evaluate tumor growth and its response to a known chemotherapeutic drug or panel of drugs. Both techniques have been proposed as an aid in the selection of cancer treatments based on responsiveness of individual tumors. Examples of chemoresistance assays include, but may not be limited to: Extreme drug resistance EDR assay, Duke University chemotherapy assessment test.
The Prosigna Assay is an in vitro diagnostic tool that provides a risk category and numerical score for assessing the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative stage I or II or node-positive stage II hormone receptor-positive breast cancer. Based on the PAM50 gene signature, the assay measures gene expression levels of RNA extracted from formalin-fixed, paraffin-embedded breast tumor tissue previously diagnosed as invasive breast carcinoma. NanoString Technologies